Free Webinar | How to Minimize the Pain of Getting Your Technical Documentation Through the Notified Body Review

June 19, 2023

Date: 19 June, 2023

Time: 17:00 – 17:45 CEST | 11:00 – 11:45 AM EST | 8:00 – 8.45 AM PDT

Location: Virtual

Language: English


Manufacturers are responsible for ensuring medical devices meet all applicable requirements of the (EU) 2017/745 Medical Devices Regulation (MDR) prior to them being placed on the European market. technical documentation(s) is required for all classes of devices and all but class I technical documentation must be evaluated by a Notified Body.

In this webinar, attendees will learn ways to minimize the pain of getting your technical documentation through the review performed by the Notified Body.

Learning Objectives

  • Learn about pitfalls when submitting your technical documentation for approval and suggestions on how to avoid them
  • Common areas of questions from Notified Bodies regarding your technical documentation and examples of the tools we will use to minimize the chance of questions from the Notified Body
  • How our services can support your technical documentation and QMS submissions 

Who should attend?

  • Regulatory specialists, experts, managers, directors
  • QA specialists, experts, managers, directors
  • PRRC
  • Project managers
  • Managers with strategic decision making
  • Start-ups

The webinar closes with a 15-minute Q&A for which you can send in questions prior to or during the webinar. Use the registration form to send in questions, e-mail them to marketing@qservegroup.com, or use the ‘Question Tab’ during the webinar.

The recording and slides will be shared with all registrants after the webinar.

Your Qserve hosts:

Keith Morel, PhD
Robert Paassen, MSc
Post date: April 14, 2023
How can we help you? Contact us